BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO II SAVVI SERIES 300 PULSE GENERATOR

    MDR report key: 83524 · Received April 8, 1997

    Report

    Report Number
    2522457-1997-00005
    Event Type
    Injury
    Date Received
    April 8, 1997
    Date of Event
    February 19, 1997
    Report Date
    March 11, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/20/96, A 76 YR OLD MALE PT WAS IMPLANTED WITH A SINGLE-LEAD ATRIAL SYNCHRONOUS VENTRICULAR PACEMAKER SYSTEM. ON 3/11/97, THE MFR RECEIVED A REPORT THAT THE ABOVE REFERENCED PT HAD DEVELOPED AN INFECTION 3 MONTHS POST-IMPLANT. ON 2/19/97, THE PHYSICIAN ELECTED TO EXPLANT THE PULSE GENERATOR AND LEAD. A NEW PACEMAKER AND LEAD WAS IMPLANTED FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO II SAVVI SERIES 300 PULSE GENERATOR Implant PACEMAKER DXY CARDIAC CONTROL SYSTEMS, INC 333 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization